The Recall Desk
ModerateFDA (Devices)·Z-0524-2021·Announced 2020-12-09

ROi CPS Recalls Labor and Delivery Kits Due to Labeling Error

ROi CPS LLC is recalling 220 labor and delivery kits because of an incorrect expiration date on the label.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling error (incorrect expiration date) without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

ROi CPS LLC is recalling 220 labor and delivery kits, which are obstetric gynecologic specialized manual instruments. The recall is being conducted due to a labeling error involving an incorrect expiration date.

The affected products were distributed nationwide in the United States, specifically in the states of Missouri and Oklahoma. The recall covers kits with lot numbers 78483C, 79932C, 81043C, 82586C, and 83090C.

Consumers and healthcare facilities should check their inventory for these specific lot numbers. If the products are found, they should be removed from use and returned to the distributor or manufacturer according to the recall instructions.

The recalled product

Product
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
Manufacturer
ROi CPS LLC
Affected units
220

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lot Numbers: 78483C
  • 79932C
  • 81043C
  • 82586C
  • 83090C.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically: